ABSTRACT:
Eighty of world population is dependent on herbal drugs and to enter into the global market it is vital to maintain its quality. The quality of herbal drugs is the sum of all factors which contribute directly or indirectly to the safety, effectiveness and acceptability of the product .Standardization of drugs means confirmation of its identity and determination of its quality and purity. Initially the crude drugs were identified by comparison only with the standard description available. At present due to advancement in the chemical knowledge of crude drugs various methods like botanical, chemical, spectroscopic and biological methods are used for estimating active constituents present in the crude drugs in addition to its physical constants.

Isolation of chemical markers for fixing pharmacopo eial standards of single and compound formulations

Phytochemistry

Isolation of compounds by chromatography

PROCESS CONTROL OF HERBAL DRUGS: Drugs are manufactured from different raw materials by using different methods or process. Some impurities are incorporated into the material during the manufacturing process. Multiple-step procedure which produces intermediate compounds. In- process control provides information on general characters, identification test and other applicable tests such as inorganic and heavy metal impurity, microbial limit, and pesticide reside besides, safety, assay and stability. In addition to the foregoing portions of the initial final and in process samples are used for collecting average run samples for the quality control laboratory to perform final batch analysis and release. Process control is shown in figure 3. CONTROL OF FINISHED PRODUCT: Specification for finished product should be defined. Final testing of finished product is made in the quality control laboratories. These tests are designed to determine compliance with specifications. Thus the testing of the finished product for compliance with predetermined standard prior to release of the product for packaging and subsequent distribution is a critical factor for quality

assurance. This testing along with in process testing, assures that each unit contains the amount of drug claimed on the label, that all of the drug in each unit is available for complete absorption, that the drug is stable in the formulation in its specific final container closure system for its expected shelf life and that dosage units. themselves contain no toxic foreign substances. The label of herbal medicine should have all the particulars required by national regulations. The label and package insert should have at least the following information. Name of the product. List of active ingredient together with Latin botanical name and their quantities. Dosage form. Indication. Dosage for adults, children and elderly. Mode of administration. Duration of use. Major adverse effects, if any. Over dosage information. Contraindication, warning precautions and major drug interactions. Use during pregnancy and lactation. Expiry date. Batch /lot number. Name, address of the manufacturer together with authorization number.
Figure 3. Flow chart of process control of herbal drugs Collection of herbal Source

CONCLUSION:
The pharmacopoeial standards in Ayurvedic Pharmacopoeia of India are not adequate enough to ensure the quality of plant materials since the materials received in the manufacturing premises are not in a condition that effective microscopic examination can be done. Therefore chemical, methods, instrumental methods and then layer chromatographic analysis would determine the proper quality of plant material Thus we can ensure consistent quality of herbal product through following. Use of approved quality of all raw materials. Use of all approved packing material. Standardized and well validated methods of processing and manufacture. Complete finished product quality control testing.